A prospective randomized trial of mycophenolate mofetil with neoral or tacrolimus after orthotopic liver transplantation

Background. The success of liver transplantation in this decade has become the stimulus to extend the donor and recipient pool. Reducing early posttra nsplant morbidity to maintain our success, as we expand our frontiers, has led us to focus on balanced testing of multidrug immunosuppression regimens . Methods. A prospective trial in orthotopic liver transplantation using Myco phenolate Mofetil and an identical steroid taper with randomization of pati ents to Neoral (N) or Tacrolimus (FK) is the basis of this report. This was an intent-to-treat study designed to compare the 6-month primary endpoints of rejection and Infection and to compare the 6-month secondary endpoints of liver function, renal function, bone marrow function, hypertension, and serum cholesterol levels. Results. Ninety-seven patients completed the 6-month follow-up period (N=49 , FK=48). The actual 6-month patient and graft survival rates were 98% and 94%, respectively. There was no difference in the number of patients with r ejection episodes (N=11, FK=8) (P=0.61). There were 24 infections (3 cytome galovirus) in the FK group and 30 infections (9 cytomegalovirus) in the N g roup. The cholesterol levels at 6 months were not significantly different ( P=0.07) between the groups. The other secondary 6-month endpoints were not significantly different, except total bilirubin, which was lower in the FK arm (P=0.02). Conclusions. The use of Mycophenolate Mofetil with N or FK and an identical steroid taper after orthotopic liver transplantation is associated with ex cellent graft and patient survival, and at 6 months, only 19% of the patien ts experienced rejection, with a 48% overall infection rate.